Regulatory plans for ATMP

Description

Regulatory aspects of ATMPs, difference between EU, US and Canadian regulatory systems

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This course will broadly cover fundamentals and preliminary requirements needed for successful cell therapy clinical trial applications (CTA). Upon completion, participants will be able to discuss and contribute to conversations around global clinical trial regulatory plans, identify the contents of a CTA and the basic differences between the Canadian, US, and EU regulatory activities surrounding clinical trials. Participants will subsequently gain confidence for approaching regulatory interactions for their own CTAs.

Planning for Cell Therapy Clinical Trial Applications